CHLORHEXIDINE/CHLOROBUTANOL VIATRIS 0,5 ml/0,5 g for 100 ml mouthwash in bottle Bottle/200ml

Mouthwash solution.

Chlorhexidine digluconate solution ............................................................................................... 0,5 mL

Chlorobutanol hemihydrate .......................................................................................................................... 0,5 g

For 100 mL of mouthwash solution.

Alcohol content: 42,8 % (v/v).

Excipients with known effect: ethanol (35,66 g), carmine red A (E124) (0,0028 g).

Excipients:

Adjunctive local treatment of conditions of the oral cavity and during post-operative care in odontology and stomatology.

This medicine is indicated in adults, adolescents and children aged over 6 years.

Dosage

The usual dose is 10 to 15 mL of solution 2 times a day.

If necessary, this dosage may be increased to 3 times a day, the maximum dose being 20 mL (to be diluted), 3 times a day.

The duration of treatment may be 2 weeks in gingival inflammation (gingivitis) and periodontitis. The duration of treatment may not be extended beyond 2 weeks except on medical advice.

If there is no improvement after 5 days, the need to continue treatment must be assessed by a doctor or dentist.

Paediatric population

This medicine is contraindicated in children under 6 years (see section Contraindications).

Method of administration

Local use as a mouthwash.

Do not swallow.

Brush your teeth before each use and rinse your mouth thoroughly with water before using CHLORHEXIDINE/CHLOROBUTANOL VIATRIS.

For the bottle, dilute in the measuring cup, filling up to the upper line with lukewarm water: carry out the mouth rinse until the measuring cup is empty. Leave the solution in contact for 1 minute, then spit it out.

For the single-dose bottle, dilute the contents of the bottle in half a glass of water and perform the mouth rinse. Leave the solution in contact for 1 minute then spit it out.

Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

In children under 6 years.

Local use as a mouthwash. 

Do not swallow the solution. 

Do not allow CHLORHEXIDINE/CHLOROBUTANOL VIATRIS to come into contact with the eyes, nose and ears. In case of contact, rinse immediately and abundantly with water.

If symptoms persist beyond 5 days and/or if associated fever occurs, the advice of a doctor or dentist must be sought.

This medicine may cause severe generalised allergic reactions due to the presence of chlorhexidine, which may occur a few minutes after exposure (see section Adverse effects).

Prolonged use may cause staining of the tongue, teeth, dentures or filling materials. This staining is reversible and can be avoided on teeth and filling materials by brushing the teeth daily before using the mouthwash, or by a dental solution for removable (dental) dentures.

This medicine contains:

• 7,13 g of alcohol (ethanol) per dose of 20 mL of solution, equivalent to 0,36 g/mL. Since this medicine is a mouthwash solution and is therefore not swallowed, the amount of alcohol contained in this medicine is not likely to cause any noticeable effect in usual clinical contexts. However, it must be ensured that children using the product do not swallow it. The presence of alcohol must be taken into account in cases of alcohol withdrawal.

• An azo dye "cochineal red A (E124)" which may cause allergic reactions.

 

Precautions for use

This product contains terpene derivatives as excipients, which may lower the epileptogenic threshold if swallowed (see section Overdose). This must be taken into account in cases of a history of epilepsy.

Chlorhexidine is incompatible with anionic agents generally present in conventional toothpastes. Therefore, the mouth must be rinsed thoroughly with water after brushing the teeth with a toothpaste, before using this medicine. A time interval must be observed between the use of the 2 products.

Pregnancy

There are no data or only limited data (fewer than 300 pregnancies) on the use of chlorhexidine and chlorobutanol in pregnant women.

Animal studies carried out with chlorhexidine have not shown any direct or indirect harmful effects (under normal conditions of use) on reproduction. An animal study showed reproductive toxicity after oral administration of chlorobutanol (see section Preclinical safety).

As a precaution, it is preferable to avoid the use of CHLORHEXIDINE/CHLOROBUTANOL VIATRIS during pregnancy.

Breast-feeding

It is not known whether chlorhexidine and chlorobutanol are excreted in breast milk.

CHLORHEXIDINE/CHLOROBUTANOL VIATRIS contains terpene derivatives as excipients. Data on the kinetics of excretion into milk are limited.

A risk for newborns / infants cannot be excluded. CHLORHEXIDINE/CHLOROBUTANOL VIATRIS must not be used during breastfeeding.

Fertility

Chlorhexidine has no effect on fertility. A study conducted in rats showed harmful effects on female fertility after oral administration of chlorobutanol (see section Preclinical safety).

No study on the ability to drive vehicles and use machines has been performed with chlorhexidine/chlorobutanol.

Undesirable effects are listed below by system organ class and by frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10 000, < 1/1000), very rare (< 1/10 000), and not known (cannot be estimated from the available data).

System organ class	MedDRA classification  (Preferred terms) (frequency unspecified)
Immune system disorders	• Anaphylactic shock, anaphylactic reaction* • Hypersensitivity to chlorhexidine or to any of the constituents of the solution
Nervous system disorders	• Dysgeusia • Mucosal burning sensation These effects may appear at the start of treatment and generally decrease with continued treatment.
Gastrointestinal disorders	• Brown discolouration of the tongue, reversible on stopping treatment (see section Warnings and precautions) Brown discoloration of teeth, dental prostheses or filling materials, reversible upon discontinuation of treatment (see section Warnings and precautions) Swelling of the parotid glands, reversible upon stopping treatment • Oral desquamation: if this occurs, diluting the mouthwash solution with more than 50 % water will often allow continued use of the mouthwash.

* Risk of generalised allergy to chlorhexidine, which may lead to anaphylactic shock that could be fatal if medical care is not provided immediately. It may manifest as difficulty breathing, facial swelling, severe skin rash.

If the patient has an allergic reaction to chlorhexidine, they must immediately stop using this product and consult a doctor.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

Overdose is not expected under normal conditions of use of this mouthwash solution.

Symptoms in case of ingestion

Systemic effects are rare because chlorhexidine is poorly absorbed by the gastrointestinal tract.

Local effects such as local irritation (throat, oesophagus) and burning sensation (mouth, throat) may occur.

However, in cases of massive ingestion and systemic absorption, the following disorders may occur:

• neurological or hepatic disorders;

gastrointestinal disorders (nausea, vomiting, epigastric pain, diarrhoea). This medicine contains terpene derivatives as excipients, which may lower the epileptogenic threshold and cause, in case of ingestion at excessive doses, neurological disorders such as convulsions, in particular in children or in case of a history of epilepsy.

 

Follow the posology, the method of administration and the duration of treatment (see section Dosage and administration).

Treatment

Treatment is symptomatic and must be administered in a specialised setting.

Due to the alcohol content of the undiluted product, accidental ingestion of a large quantity of the mouthwash by children requires immediate medical attention for appropriate action.

Pharmacotherapeutic class: stomatological preparations - anti-infectives and antiseptics for local oral treatment, ATC code: A01AB03.

Chlorhexidine is a broad-spectrum bactericidal antiseptic belonging to the bisdiguanide family.

The antiseptic activity of the CHLORHEXIDINE/CHLOROBUTANOL VIATRIS mouthwash solution has been demonstrated in vitro in particular against pathogenic germs of the oral flora such as Porphyromonas gingivalis, A. actinomycetemcomitans, Prevotella intermedia, Capnocytophaga ochracea, Eikenella corrodens, Fusobacterium nucleatum, Campylobacter rectus.

By its antiseptic activity, the CHLORHEXIDINE/CHLOROBUTANOL VIATRIS solution helps reduce dental plaque and, consequently, gingival inflammation.

Chlorobutanol has antibacterial and antifungal properties. It is also used as a local analgesic in preparations for inflammation and pain of the ear and oropharynx.

CHLORHEXIDINE

Oral use

Absorption

Chlorhexidine is poorly absorbed and very low concentrations of circulating chlorhexidine are detected in the blood.

Distribution

Mainly in the liver and kidneys.

Metabolism and elimination

Chlorhexidine undergoes limited metabolism and is excreted essentially unchanged in the faeces (99,5 % of the ingested dose).

Oral route

Absorption: when used locally, chlorhexidine is adsorbed onto dental enamel, dentine, cementum, mucous membranes and dental prostheses with slow desorption. Chlorhexidine remains detectable in saliva for 8 to 12 hours.

Due to its cationic nature, chlorhexidine digluconate binds strongly to the skin, mucous membranes and other tissues. It is therefore very poorly absorbed.

After contact with mucous membranes, chlorhexidine is absorbed by organic structures, which results in a local residual effect and limits passage into the systemic circulation.

CHLOROBUTANOL

Oral use

Absorption

When administered orally, chlorobutanol is rapidly absorbed. A reduction in absorption by half is observed during the 24 hours after intake.

Elimination

The terminal half-life is approximately 10 days. Urinary excretion is low, approximately 10 % of the ingested dose.

CHLORHEXIDINE

Non-clinical data from conventional studies of safety pharmacology, repeated-dose toxicity and local tolerance, genotoxicity, carcinogenesis, and reproductive and developmental functions did not reveal any particular risk for humans.

In repeated-dose oral studies, effects were observed in animals only at exposures considered sufficiently higher than the maximum exposure observed in humans, and have little clinical significance after topical application.

CHLOROBUTANOL

A combined repeated-dose toxicity study with reproduction and developmental toxicity screening conducted orally in rats showed that chlorobutanol affects fertility and is embryotoxic at doses inducing maternal toxicity.

After repeated oral administration in rats, effects on the kidneys and liver were observed in both sexes. In addition, the reduction in locomotor activity was considered evidence of the sedative effects of chlorobutanol. Chlorobutanol is not genotoxic and no experimental study is available to assess its carcinogenic potential.

Before opening: 33 months.

After opening: 14 days.

Store at a temperature not exceeding 25°C.

No special requirements.

Marketing authorisation (AMM)

CIP 3400934680861 (Fl/90 ml). CIP 3400934680922 (Fl/200 ml). CIP 3400934681172 (Fl/500 ml + dosing cup).

Price:

1,58 euros (Fl/90ml).

Reimbursed by social security at 15% (Fl/90ml).
Not reimbursed by social security (Fl/200ml, Fl/500ml+dosing cup).
Collect (Fl/90ml).